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GLP-1 Receptor Agonist

Semaglutide for Opioid Use Disorder (SHORE Trial)

Phase 2

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Initiated sublingual buprenorphine (SL-BUP) treatment within 60 days of enrollment

Be older than 18 years old

Must not have

Current or lifetime diagnosis of Type 1 or Type 2 diabetes

Use of any GLP-1 agonist medications in the prior 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly from baseline to end of study at 14 weeks

Summary

This trial is testing the effects of semaglutide on people with opioid use disorder who are starting buprenorphine treatment. Participants will receive either semaglutide injections or a placebo for

Who is the study for?

This trial is for individuals starting treatment with buprenorphine for opioid use disorder. Participants will be randomly assigned to receive either semaglutide or a placebo in weekly injections over 12 weeks.

What is being tested?

The study tests if semaglutide affects cravings and reactions to drug cues in people with opioid addiction. It's also looking at how safe and tolerable the drug is as a potential treatment option.

What are the potential side effects?

Possible side effects of semaglutide may include digestive issues like nausea, vomiting, diarrhea, constipation, and abdominal pain; risk of low blood sugar; headache; fatigue; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I started taking buprenorphine under the tongue within the last 60 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with diabetes.

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I haven't taken any GLP-1 agonist medications in the last 3 months.

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I plan to take GLP-1 agonist medications during the trial.

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My liver function tests are more than three times the normal limit, or I have severe kidney problems.

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I or my family have a history of thyroid cancer or MEN2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly from baseline to end of study at 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly from baseline to end of study at 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly from baseline to end of study at 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cue-induced Cravings for Opioids

Relapse to Illicit Opioid Use

Secondary study objectives

Assessment of blind

Blood pressure

Blood sugar

+16 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848

21%

Nausea

12%

Decreased Appetite

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention

This arm will receive semaglutide (n=23). All participants will initially receive 0.25mg for 4 weeks, and then as tolerated dose will be increased to 0.5mg for 4 weeks. Then as tolerated, the dose will be increased to 1.0mg for 4 weeks.

Group II: PlaceboPlacebo Group1 Intervention

This arm will receive saline placebo (n=23).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2021

Completed Phase 4

~5160

0 / 6Eligibility criteria met